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采用序贯试验设计比较自我给药米索前列醇与安慰剂用于宫腔镜手术前宫颈成熟的效果。

Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design.

作者信息

Oppegaard K S, Nesheim B-I, Istre O, Qvigstad E

机构信息

Department of Gynaecology, Helse Finnmark, Klinikk Hammerfest, Hammerfest, Norway.

出版信息

BJOG. 2007 Jun;114(6):769, e1-12. doi: 10.1111/j.1471-0528.2007.01339.x.

DOI:10.1111/j.1471-0528.2007.01339.x
PMID:17516971
Abstract

OBJECTIVE

To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy.

DESIGN

Randomised, double-blind, placebo-controlled sequential trial.

SETTING

Norwegian university teaching hospital.

SAMPLE

Premenopausal and postmenopausal women referred to outpatient resectoscopy.

METHODS

The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy.

MAIN OUTCOME MEASURES

Preoperative cervical dilatation, acceptability and complications.

RESULTS

(a) Intraoperative findings and distribution of cervical dilatation in the two treatment groups. Values are given as median (range) or n (%). (b) Acceptability in the two treatment groups. Values are given as completely acceptable, n (%); fairly acceptable, n (%); fairly unacceptable, n (%) and completely unacceptable, n (%). (c) Pain in the two treatment groups. Pain was measured with a visual analogue scale score, scale ranges from 0 (no pain) to 10 (unbearable pain). Values are given as median (range). (d) Occurrence of adverse effects in the two treatment groups. Values are given as n (%). (e) Complications, given as n (%).

摘要

目的

比较门诊宫腔镜电切术前,1000微克米索前列醇阴道给药与阴道安慰剂给药对绝经前和绝经后女性术前宫颈成熟的影响。

设计

随机、双盲、安慰剂对照序贯试验。

地点

挪威大学教学医院。

样本

转诊至门诊进行宫腔镜电切术的绝经前和绝经后女性。

方法

女性在门诊宫腔镜电切术前一晚被随机分为两组,一组阴道给予1000微克米索前列醇,另一组阴道给予安慰剂。

主要观察指标

术前宫颈扩张情况、可接受性及并发症。

结果

(a)两个治疗组的术中发现及宫颈扩张分布情况。数值以中位数(范围)或n(%)表示。(b)两个治疗组的可接受性。数值以完全可接受,n(%);尚可接受,n(%);不太可接受,n(%)和完全不可接受,n(%)表示。(c)两个治疗组的疼痛情况。疼痛采用视觉模拟评分法测量,评分范围为0(无疼痛)至10(难以忍受的疼痛)。数值以中位数(范围)表示。(d)两个治疗组不良反应的发生情况。数值以n(%)表示。(e)并发症,以n(%)表示。

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引用本文的文献

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J Nat Sci Biol Med. 2015 Aug;6(Suppl 1):S123-7. doi: 10.4103/0976-9668.166116.
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BJOG. 2008 Apr;115(5):663, e1-9. doi: 10.1111/j.1471-0528.2007.01628.x. Epub 2008 Jan 16.